Sr Clinical Data Coordinator (Lead DM)

Job Overview:

• Review clinical trial data in accordance with [Global] Data Management Plans and applicable standardized data management processes (SOPs, Work Instructions, etc.) to identify erroneous, missing, incomplete, or implausible data

• Run ancillary programs (e.g., diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trial data

• Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database

• Interact with the dictionary coding and maintenance group to ensure appropriate process set-up and application

• Perform reconciliation of the clinical and safety databases

• Perform reconciliation of central laboratory and/or third party vendor data (eCRF, eDiary, specialty laboratory, etc.)

• Perform aggregate review of clinical data by patient, site, and/or project to identify data trends (patient safety, compliance, etc.), and/or data inconsistencies that require further investigation

• Apply quality control procedures and checks to ensure data quality standards (client and Covance) are achieved

• Serve as a reviewer of project documents such as protocols, CRFs (or eCRFs and eDiary), monitoring conventions, CRF (eCRF) completion guidelines, etc.

• Assist with the development of [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data

• Assist in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications

• Assist in the creation of data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion / monitoring conventions

• Assist in the development and testing of data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities

• Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality

• Serve as client contact for project meetings and CDM status updates

• Potentially support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.

• Support the training of project staff on project-specific, global, standardized data management processes

• Maintain technical data management competencies via participation in internal and external training seminars

• Review literature and research technologies/procedures for improving global data management practices

• Perform other duties as assigned by managementEducation/Qualifications:

Minimum required:

• University/ college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing certification, medical or laboratory technology).

•In lieu of the above requirement, approximately 18 months experience in related field incorporating approximately 1 year’s clinical data management experience in addition to the 4 years relevant work experience in data management will be considered

•Broad knowledge of drug development process

•Understanding of global clinical development budgets and relationship to productivity targets

•Knowledge of effective clinical data management practices

•Cursory knowledge of time and cost estimate development and pricing strategies

•Thorough knowledge o ICH guideline and GCP including international regulatory requirements for the conduct of clinical development programs.Experience:

•Minimum 4 years relevant work experience with increasing responsibility in data management with knowledge of 2 or more therapeutic areas.

•Demonstrated time management skill and ability to adhere to project productivity metrics and timelines

•Excellent oral and written communication skills and demonstrated presentation skills

•Knowledge of clinical trial processes and data management, clinical operations, biometrics, quality management, and systems applications to support operations

•Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies

•Potential ability to lead by example data management staff